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IRCT20100223003408N7 IRCT 2020-02-23 Shiraz University of Medical Sciences Investigating the Effects of Single Dose and Co-Supplementation of Vitamin D and Omega-3 in women with poly cystic ovary syndrome Investigating the Effects of Single Dose and Co-Supplementation of Vitamin D and Omega-3 on Anthropometric Factors, Lipid and Glycemic Profile, and the Status of Sex Hormone Binding Globulin in Women with Polycystic Ovary Syndrome 2017-04-05 anticipated 107 Complete https://irct.ir/trial/37496 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: samples were categorized using a Permuted block randomization method (29) based on whether or not using OCP by using Random Allocation Software as 1: 1: 1: 1 and equally to one of the 4 groups, Blinding description: Blinded groups in the study include participants and researchers. After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. The doctor is given a table of coded numbers in advance, and the patients are entered into the study in the order of the numbers in the table. Therefore, the present study is double-blind. Vitamin D, Omega-3 and placebo capsules have the same shape, color, and size and are delivered to the patient in the package. N/A polycystic ovary syndrome. Intervention 1: Vitamin D group: received one vitamin D capsule (Zahravi Pharmaceutical Company, Tehran, Iran) (50000 IU/weekly) + two placebo capsules (paraffin oil; daily). Intervention 2: Omega-3 (O3) group: received two O3 capsules (Zahravi Pharmaceutical Company, Tehran, Iran) daily (each one contained 360 mg eicosapentaenoic acid (EPA) and 240 mg docosahexaenoic acid (DHA) ) + one placebo capsule (paraffin oil; weekly). Intervention 3: Vitamin D + O3 group: received one vitamin D capsule (50000 IU/weekly) + two O3 capsules daily (each one contained 360 mg EPA and 240 mg DHA ). Intervention 4: Placebo group: received one placebo capsule (paraffin oil; weekly) + two placebo capsule (paraffin oil; daily). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Dr.Maryam Ekramzade
Razi-Blvi
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1006 M_Ekramzade@yahoo.com Shiraz University of Medical Sciences scientific Dr.Maryam Ekramzade
Razi-Blv
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1006 M_Ekramzade@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) This syndrome is defined by the Rotterdam Diagnostic Criteria by Gynecologist Excluding any drug or surgical treatment to treat clinical symptoms associated with polycystic ovary syndrome except ocp No history of any allergy, intolerance or harmful drug reaction to the studied supplements Age range ..18-45 Being within the BMI range of 18.5-40 Ability to understand study objectives and provide written informed consent Residence in Shiraz and willingness to participate in the study 18 years 45 years Female Suffering from hormonal disorders including Edison's disease, Cushing's disease, hyperparathyroidism, hypo- or hyperthyroidism Having history of chronic diseases including cancer, heart disease, diabetes, stroke, fibromyalgia, kidney, or liver defects Having history of food and drug allergies Starting drug or surgical therapy for clinical symptoms associated with PCOS except oral contraceptive pills (OCPs) Smoking or any drug addiction Pregnancy and lactation Being on a special diet in the last year Using any dietary supplement, Having oral or injectable nutritional supplements containing vitamin D in the last 3 months Consuming nutritional supplements containing fish oil or Omega-3 fatty acids in the last 3 months Having fish in the diet more than 3 servings per week during last 3 months History of severe side effects or symptoms of poisoning with the current study supplements Lack of adherence to the study protocol E28.2 polycystic ovary syndrome Treatment - Other Treatment - Other Treatment - Other Treatment - Other Vitamin D group: received one vitamin D capsule (Zahravi Pharmaceutical Company, Tehran, Iran) (50000 IU/weekly) + two placebo capsules (paraffin oil; daily). Omega-3 (O3) group: received two O3 capsules (Zahravi Pharmaceutical Company, Tehran, Iran) daily (each one contained 360 mg eicosapentaenoic acid (EPA) and 240 mg docosahexaenoic acid (DHA) ) + one placebo capsule (paraffin oil; weekly). Vitamin D + O3 group: received one vitamin D capsule (50000 IU/weekly) + two O3 capsules daily (each one contained 360 mg EPA and 240 mg DHA ). Placebo group: received one placebo capsule (paraffin oil; weekly) + two placebo capsule (paraffin oil; daily). TG. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer. TC:total cholesterol. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer. HDL-C:high-density lipoprotein cholesterol. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer. LDL-C:Low-density lipoprotein cholesterol. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer. Sex hormone binding globulin :SHBG. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: ELISA. FBS: fasting blood sugar. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer. Physical Activity. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: questionnaire. Weight. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Low-weight, no-shoe weight using Digital Balance Digital Balance. BMI:body mass index. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Formula. WC: Waist circumference. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Meter. Homeostasis model assessment insulin resistance (HOMA-IR). Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Formula. Serum Insulin. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: ELISA. Height. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: With minimum coverage and no shoes, using wall meter. Shiraz University of Medical Sciences Approved 2018-01-31 shiraz university of medical science zand street shiraz Fars Iran (Islamic Republic of)